Innovent's Phase 3 GLORY-1 obesity study published in NEJM

Innovent's Phase 3 GLORY-1 obesity study published in NEJM

By, Admin 28 May 2025

In a landmark development for metabolic disease management, The New England Journal of Medicine (NEJM) has published the results of Innovent Biologics’ pivotal phase 3 clinical trial of mazdutide, a first-in-class dual GLP-1/glucagon receptor agonist, in Chinese adults with overweight or obesity.

The trial, GLORY-1, not only marks a breakthrough for Chinese drug innovation but also establishes mazdutide as a globally significant contender in obesity treatment.

This is the first clinical study of mazdutide, and the first China-developed obesity drug study, to be published in NEJM, signaling global recognition of China’s growing capabilities in clinical research and biotechnology. The paper was co-authored by Professor Linong Ji (Peking University People’s Hospital) and Dr. Lei Qian from Innovent.

GLORY-1 Trial: A Snapshot of Efficacy

The GLORY-1 trial enrolled 610 participants with BMI ≥28 kg/m² (obese) or BMI 24–28 kg/m² (overweight) and at least one obesity-related comorbidity. Participants received mazdutide 4 mg, 6 mg, or placebo, administered subcutaneously once weekly for 48 weeks.

Key findings:

  • Weight loss at Week 48:
    • Mazdutide 4 mg: -12.05%
    • Mazdutide 6 mg: -14.84%
    • Placebo: -0.47%
  • At Week 32, ≥5% weight reduction was achieved in:
    • 76.3% of 4 mg group
    • 84.0% of 6 mg group
    • Compared to just 10.9% in placebo
  • At Week 48, ≥15% weight reduction was achieved by:
    • 37.0% (4 mg)
    • 50.6% (6 mg)
    • 2.1% (placebo)

Beyond Weight Loss: Liver, Lipid, and Metabolic Benefits

Mazdutide demonstrated broad-spectrum metabolic benefits:

  • Liver fat content reduced by up to 80.2% in patients with high baseline fat.
  • Significant improvements were observed in:
    • Blood pressure
    • LDL cholesterol and triglycerides
    • Uric acid
    • Liver enzymes
    • Insulin sensitivity

Importantly, no increased cardiovascular risks were noted. Common side effects—such as nausea, vomiting, and diarrhea—were mostly mild to moderate.

Experts Weigh In

An accompanying NEJM editorial by Professors Vanita R. Aroda (Harvard Medical School) and Leigh Perreault (University of Colorado) emphasized how the GLORY-1 study reflects unique characteristics of Chinese populations.

They noted earlier onset and greater metabolic risk among younger Chinese individuals compared to Western counterparts, calling for localized obesity strategies that prioritize liver health and lipid control.

They also highlighted that while pharmacologic therapy like mazdutide is impactful, it should be part of a comprehensive obesity prevention and management framework, especially in nations like China where the obesity burden is rapidly escalating.

A Homegrown Breakthrough in Endocrinology

Professor Linong Ji, the study’s lead principal investigator, commented:

"Global obesity guidelines have long relied on data from Western populations. This NEJM publication not only validates the clinical value of mazdutide but also represents a watershed moment for Chinese metabolic research."

Dr. Lei Qian of Innovent added:

“Mazdutide’s global debut via NEJM sets the tone for its role in reshaping metabolic disease care. It validates years of innovative R&D and will soon offer a tailored, evidence-based treatment option for China’s overweight and obese population.”

Strategic Partnerships and Future Plans

Mazdutide, known as OXM3 in early development, was co-developed under an exclusive licensing agreement between Innovent Biologics and Eli Lilly for the China market. The drug is a mammalian oxyntomodulin analogue, activating both GLP-1 and glucagon receptors, thereby promoting insulin secretion, enhancing fat metabolism, and increasing energy expenditure.

Currently, two New Drug Applications (NDAs) for mazdutide are under review by China’s NMPA:

  • Chronic weight management in adults with overweight or obesity
  • Glycemic control in adults with type 2 diabetes

Mazdutide is being evaluated across six phase 3 studies under the GLORY and DREAMS series:

  • GLORY-2: Moderate-to-severe obesity
  • GLORY-3: Obesity with metabolic dysfunction-associated fatty liver disease (MAFLD)
  • DREAMS-1/2/3: Various cohorts of type 2 diabetes patients

Future trials are planned in adolescents, sleep apnea, MASH, and heart failure with preserved ejection fraction (HFpEF).

Obesity in China: An Urgent Challenge

China has the largest global population with overweight or obesity, contributing to 11.1% of chronic disease-related deaths in 2019—nearly double the 1990 rate. Despite increasing awareness, effective and sustainable pharmacotherapies remain limited. Mazdutide is poised to change that landscape.

With approval expected later this year, mazdutide could become a cornerstone therapy in China’s national health strategy, Healthy China 2030, and a harbinger of Asia’s growing clout in pharmaceutical innovation.

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